# US 12,201,681 B2 · Removal of agglomerates

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- Number: US 12,201,681 B2
- Document ID: US12201681B2
- Status: Granted
- Kind: B2
- Application number: 18/161,210
- Filed: 2023-01-30
- Published: 2023-10-05
- Granted: 2025-01-21
- Earliest claimed: 2018-07-10
- Assignees: Seqirus Pty Ltd
- Applicants: Seqirus Pty Ltd
- Inventors: Steven Rockman; Jesse Bodle; Nancy Guzzo-Pernell
- Web page: https://patentgrep.com/patent/US12201681B2

## CPC

- A61K 39/12: Viral antigens
- A61K 39/145: Orthomyxoviridae, e.g. influenza virus
- B01J 19/10: employing sonic or ultrasonic vibrations
- C12N 13/00: Treatment of microorganisms or enzymes with electrical or wave energy, e.g. magnetism, sonic waves
- A61K 2039/5252: {inactivated (killed)}
- A61K 2039/70: {Multivalent vaccine}
- C12N 2760/16134: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2760/16234: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- B01J: CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

The present disclosure provides a method of dispersing agglomerated material in a preparation comprising influenza proteins. The method comprises subjecting the preparation to sonication.

## Claims

### Claim 1

An influenza vaccine, the vaccine comprising a preparation of inactivated or split influenza virions, wherein the preparation has been subjected to sonication and wherein the sonication is conducted at a rate of 80% amplitude, further wherein an optical density turbidity (ODT) of the inactivated or split influenza virions ranges from 50% to 80%.

### Claim 2 (depends on 1)

The influenza vaccine according to claim 1, wherein the vaccine comprises at least 3 different influenza strains.

### Claim 3 (depends on 1)

The influenza vaccine according to claim 1, wherein the vaccine is a monovalent vaccine or a quadrivalent vaccine.

### Claim 4 (depends on 1)

The influenza vaccine according to claim 1, wherein the vaccine comprises influenza A and influenza B.

### Claim 5 (depends on 1)

The influenza vaccine according to claim 1, wherein the vaccine is substantially free of agglomerated material.

### Claim 6 (depends on 1)

The influenza vaccine according to claim 1, wherein the preparation has additionally been subjected to sonication conducted to transfer at least 90 Joules/mL of energy.

### Claim 7 (depends on 2)

The influenza vaccine according to claim 2, wherein the at least 3 influenza strains are selected from the group consisting of two influenza A virus strains and one influenza B virus strain.

### Claim 8 (depends on 2)

The influenza vaccine according to claim 2, wherein the at least 3 different influenza strains comprise an H3N2 virus strain and an H1N1 virus strain.

### Claim 9 (depends on 8)

The influenza vaccine according to claim 8, wherein the influenza H3N2 virus strain that has a predicted HA glycosylation site probability score (pGly score) ≥16 requires sonication of ≥90 Joules/mL.

### Claim 10 (depends on 8)

The influenza vaccine according to claim 8, wherein the influenza H1N1 virus strain that has a predicted HA glycosylation site probability score (pGly score) ≥11 requires sonication of ≥90 Joules/mL.
